Diseases of Mitral Valve, Heart; Disease, Mitral(Valve), Heart; Dysfunction Postoperative, Cardiac Surgery, Heart Valve Diseases, Mitral Valve Insufficiency
Conditions
Brief summary
Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed. Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.
Interventions
None listed
Sponsors
UMC Utrecht
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; * Male or female from all ethnicities; * At least 6 months post successful, isolated MV repair. S * Asymptomatic
Exclusion criteria
* Pulmonary hypertension \>50 mmHg at rest; * Atrial fibrillation (AF) at time of study related stress echo test; * Known contraindication or incapability to perform peak exercise or inability to perform physical stress testing; * LVEF \<45%; * NYHA class II and more. * Other heart valve disease of more than mild severity; * Concomitant surgery during MV repair, e.g. MAZE, TVP procedure; * Prior heart valve surgery; * Congenital heart disease; * Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD); * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic parameter: Peak mitral valve mean gradient (mmHg) | at least 6 months after successful MV repair | Echocardiographic measured mitral valve mean gradient at peak physical exercise |
| Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg) | at least 6 months after successful MV repair | Echocardiographic measured sPAP at peak physical exercise |
| Echocardiographic parameter: Increase in mitral valve regurgitation grade (grade 0-4, according to ESC guidelines) | at least 6 months after successful MV repair | Echocardiographic measured increase in mitral valve regurgitation at peak physical exercise during physical stress echo, compared to rest echo. Grading of mitral regurgitation will be performed according to the ESC guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic parameter: Left ventricular function (LVF, quality description) | at least 6 months after successful MV repair | Echocardiographic measured LVF quality at rest and peak physical exercise |
| Echocardiographic parameter: Mitral valve area (MVA, cm2) | at least 6 months after successful MV repair | Echocardiographic measured MVA at rest and peak physical exercise |
| Echocardiographic parameter: Peak mitral valve peak gradient (mmHg) | at least 6 months after successful MV repair | Echocardiographic measured mitral valve peak gradient at peak physical exercise |
Countries
Netherlands
Outcome results
None listed